Events

Recall of Device Recall Bella Blankets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beekley Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62432
  • Event Risk Class
    Class 2
  • Event Number
    Z-2080-2012
  • Event Initiated Date
    2012-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110499
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, mammographic - Product Code IZH
  • Reason
    Imaging artifact can occur on mammogram result.
  • Action
    Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539.

Device

Device Recall Bella Blankets
  • Model / Serial
    Lot Numbers: 107657, 108150, 108833
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution including Nationwide(USA), and the countries of Japan and Canada.
  • Product Description
    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
  • Manufacturer
    Beekley Corporation

Manufacturer

Beekley Corporation
  • Manufacturer Address
    Beekley Corporation, 1 Prestige Ln, Bristol CT 06010-7468
  • Manufacturer Parent Company (2017)
    Beekley Corporation
  • Source
    USFDA